Job Description :
Position : Design Quality Engineer Location : West Chester, PA Mode of hiring: Long term contract Job Description: Responsible for End to End Product design Quality support, Functional Design Requirements, Verification & Validation documentation, documentations Coordinate with various Technical file cross functional teams to make sure that data is aligned across the spectrum. Ability to work in a regulated work environment and previous experience with ISO 13485 standard and FDA and MDD regulations, Knowledge in risk management (ISO 14971), Transfer data to latest documents templates per the Quality systems and write the missing requirements and map the objective evidences from all available sources Good experience in writing test protocol& Reports for Mechanical and Usability lab testing. Knowledge in Metal and Plastic Manufacturing process & Techniques. Should have resource management skills to hold discussions with the stakeholders for sharing feedback and work with them for completion, Design review & Technical guidance to the team.